Device recall
Z-0055-2025: Enterprise Imaging XERO Viewer- software application used for reference and…
FDA device recall · Class II · Agfa Healthcare NV
Key facts
| Recall number (Z-number) | Z-0055-2025 |
|---|---|
| Recall event | 95411 |
| Product | Enterprise Imaging XERO Viewer- software application used for reference and diagnostic viewing of multispecialty medical imaging and non-imaging data . Enterprise Imaging XERO Viewer 8.0.0, 8.0.1, 8.1, 8.1.1, 8.1.2, 8.1.3,8.1.4, 8.2.0.000, 8.2.1.000, 8.2.2.000, 8.3.0.000, 8.3.1.000, 8.3.2.000… |
| Product code | LLZ |
| Recalling firm | Agfa Healthcare NV |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K170434 |
| FEI number | 3009471886 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database